Alberta has temporarily suspended a province-wide trial investigating the effectiveness of hydroxychloroquine as a potential treatment for COVID-19.
A spokesperson with Alberta Health confirmed Tuesday that the “clinical trial has been temporarily suspended by the research team so they can review the literature and results from other studies, as is the case with some other clinical trials around HCQ.”
The temporary suspension comes as the World Health Organization announced Monday it was temporarily dropping hydroxychloroquine from its global study into experimental COVID-19 treatments, saying that its experts need to review all available evidence to date.
WHO director-general Tedros Adhanom Ghebreyesus said that in light of a paper published last week in the Lancet that showed people taking hydroxychloroquine were at higher risk of death and heart problems, there would be “a temporary pause” on the hydroxychloroquine arm of its global clinical trial.
Hydroxychloroquine is a drug that’s normally used to treat malaria.
Alberta’s study, titled Alberta Hope COVID-19, was announced in mid-April and planned to recruit 1,600 Albertans to determine whether a prescribed five-day treatment of hydroxychloroquine can prevent hospitalization for those at highest risk of developing a severe illness.
The clinical trial is being led by University of Calgary and University of Alberta researchers, with support from the Alberta government and Alberta Health Services.
On Tuesday, U of C professor and co-lead of the study, Dr. Michael Hill, said temporarily halting the trial is a routine decision.
“This is exactly what trial safety is about,” Hill said.
“We do this all the time in trials. We review the safety routinely and we ask those questions of: is it safe to continue?”
Hill said while the decision to pause was made due to safety concerns for the public, he noted that Alberta’s trial is very different from those citing safety concerns.
“A key thing to understand here is that the trial that was published in the Lancet — while it looked at a large number of patients — it was observational and it only applies to people who are already really sick with viral pneumonia from the SARS-CoV-2 virus,” Hill said.
“We have a different approach. The trial we’re running is asking the question: among people who have just been infected, could we stop them from getting really sick?”
Hill also noted that a similar trial in the U.K. has decided to continue operations after deeming its trial safe for patients. He said that with no safety concerns of their own so far, he expects a similar outcome for Alberta’s trial.
“We’ll consider our data in the context of everything that’s happening globally,” Hill said.
“I think the responsible thing to do is say, ‘There was a red flag, stop, step back and take a look.'”
Hill said the team has already met with the safety committee and will be doing so again on Friday to determine the trial’s safety.
Hill said if the trial is deemed safe to continue, some things may need to change moving forward.
“We’ll ask the question of if it’s safe to continue with the current design and do we need to modify anything to ensure patient safety?” he said.
Hill added that, if it’s safe to proceed, the team will also have to evaluate if the trial is feasible to continue/
“Given all of the negative press, we have to ask if people will even want to be in the trial,” he said.
So far, 148 patients have enrolled in the Alberta study. Hill said, in the trial, patients are chosen at random in a 2:1 ratio to get the study drug or a placebo. He added that approximately 100 patients have received hydroxychloroquine.
More to come…
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